Pelvic Exenteration in Treating Patients With Recurrent Cervical Cancer

May 27, 2015 updated by: Gynecologic Oncology Group

Prospective Evaluation of Pelvic Exenteration in Patients With Recurrent Cervical Cancer

This phase II trial is studying how well pelvic exenteration works in treating patients with recurrent cervical cancer. Pelvic exenteration may be effective in treating recurrent cervical cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. Correlate progression-free survival and overall survival with tumor size, time interval between primary cancer management and pelvic exenteration, and presence or absence of pelvic sidewall fixation by clinical examination in patients with recurrent cervical cancer treated with pelvic exenteration.

SECONDARY OBJECTIVES:

I. Determine quality of life of patients treated with this procedure. II. Correlate quality of life with reconstructive technique (e.g., no ostomy or ≥ 1 ostomy) in patients treated with this procedure.

OUTLINE:

Patients undergo pelvic exenteration within 14 days after study entry. Quality of life is assessed at baseline and at 6, 12, and 24 months after surgery. After completion of study treatment, patients are followed within 30 days, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28033
        • M D Anderson International Spain
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80010
        • Colorado Gynecologic Oncology Group
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
      • New Britain, Connecticut, United States, 06050
        • The Hospital of Central Connecticut
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Beebe Medical Center
      • Newark, Delaware, United States, 19718
        • Christiana Care Health System-Christiana Hospital
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Georgia Regents University Medical Center
      • Savannah, Georgia, United States, 31404
        • Memorial University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University/Melvin and Bren Simon Cancer Center
    • Maryland
      • Elkton MD, Maryland, United States, 21921
        • Union Hospital of Cecil County
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center-Fairview
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Jersey
      • Hamilton, New Jersey, United States, 08690
        • The Cancer Institute of New Jersey Hamilton
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44111
        • Cleveland Clinic Cancer Center/Fairview Hospital
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center
      • Mayfield Heights, Ohio, United States, 44124
        • Hillcrest Hospital Cancer Center
      • Mentor, Ohio, United States, 44060
        • Lake University Ireland Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
      • Tulsa, Oklahoma, United States, 74146
        • Tulsa Cancer Institute
      • Tulsa, Oklahoma, United States, 74104
        • Cancer Care Associates-Midtown
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103
        • Gynecologic Oncology Group
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center
    • Washington
      • Auburn, Washington, United States, 98001
        • Auburn Regional Medical Center
      • Centralia, Washington, United States, 98531
        • Providence Regional Cancer System-Centralia
      • Federal Way, Washington, United States, 98003
        • Saint Francis Hospital
      • Lakewood, Washington, United States, 98499
        • Saint Clare Hospital
      • Olympia, Washington, United States, 98506-5166
        • Providence - Saint Peter Hospital
      • Olympia, Washington, United States, 98507
        • Capital Medical Center
      • Puyallup, Washington, United States, 98372
        • MultiCare Good Samaritan Hospital
      • Tacoma, Washington, United States, 98405
        • MultiCare Tacoma General Hospital
      • Tacoma, Washington, United States, 98405
        • MultiCare Allenmore Hospital
      • Tacoma, Washington, United States, 98405
        • Saint Joseph Medical Center
      • Tacoma, Washington, United States, 98415
        • MultiCare Health System
      • Tacoma, Washington, United States, 98405
        • Northwest CCOP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Diagnosis of cervical cancer

    • Any histology
    • Documented or suspected central pelvic disease with or without pelvic sidewall fixation from tumor and/or radiation fibrosis

  • Meets 1 of the following stage criteria:

    • Recurrent disease, defined as reappearance of disease after a complete clinical response lasting ≥ 1 month
    • Persistent disease, defined as presence of disease by biopsy ≥ 3 months after completion of primary therapy

  • Must have received prior primary treatment, including any of the following:

    • Surgery with or without post operative radiotherapy with or without chemotherapy
    • Primary radiotherapy with or without chemotherapy
    • Neoadjuvant chemotherapy followed by surgery
    • Neoadjuvant chemotherapy followed by surgery with or without radiotherapy or chemotherapy

  • Plans to undergo pelvic exenteration to remove the pelvic disease within 14 days after study entry

    • Deemed to be a good surgical candidate

      • No evidence of distant disease or disease that is felt to be unresectable by physical examination
      • Patients with suspicious pelvic or para-aortic nodal disease as the only site(s) of extrapelvic disease are eligible at the discretion of the surgeon
    • Patients whose surgery is planned solely for managing complications (e.g., rectovaginal fistula, vesicovaginal fistula) of disease or prior therapy are not eligible
    • Patients whose surgery is planned as a prophylactic measure due to a slow or suboptimal clinical or radiographical tumor response during the course of primary therapy are not eligible
  • No distant site of metastases by CT scan or MRI of the abdomen/pelvis OR positron-emission tomography
  • No noncervical primary tumor
  • No prior anterior or posterior pelvic exenteration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (pelvic exenteration)
Patients undergo pelvic exenteration within 14 days after study entry.
Procedure: Conventional Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: From entry to protocol to death; or for living patients, the date of last contact, up to 93 years
From entry to protocol to death; or for living patients, the date of last contact, up to 93 years
Progression-free survival
Time Frame: From study entry to date of reappearance or increasing parameters of disease or death, or to date of last contact for patients without disease progression, up to 93 years
From study entry to date of reappearance or increasing parameters of disease or death, or to date of last contact for patients without disease progression, up to 93 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Impact of surgery therapy (exenteration and reconstructive surgery type) on quality of life assessed by Functional Assessment of Cancer Therapy-Cervix (FACT-CX)
Time Frame: At baseline, 6, 12, and 24 months post exenteration
At baseline, 6, 12, and 24 months post exenteration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: D. McMeekin, Gynecologic Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

September 20, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

May 29, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOG-0222 (Other Identifier: CTEP)
  • U10CA027469 (U.S. NIH Grant/Contract)
  • NCI-2009-00593 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • CDR0000442396

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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